Extranodal NK/T-cell LymphomaEBV-T/NK CohorNCT07727083
Clinical and Biological Cohort Study of EBV-Positive T/NK-Cell Lymphoproliferative Diseases
An observational study of Extranodal NK/T-cell Lymphoma and Aggressive NK-Cell Leukemia, run by Rong Tao at 1 site in China.
Trial summary
This is a multicenter, non-interventional, ambidirectional cohort study of Epstein-Barr virus-positive T/NK-cell lymphoproliferative diseases. The study consists of a retrospective clinical cohort of 500 consecutively diagnosed patients with extranodal NK/T-cell lymphoma and a prospective clinical-biological cohort of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extranodal NK/T-cell Lymphoma, Aggressive NK-Cell Leukemia, Systemic Chronic Active Epstein-Barr Virus Disease
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2026to 31 Dec 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 years or older with a newly diagnosed Epstein-Barr virus-positive T/NK-cell lymphoproliferative disease meeting World Health Organization diagnostic criteria. The retrospective cohort includes consecutive hospitalized patients with extranodal NK/T-cell lymphoma diagnosed from 2017 through 2025. The prospective cohort includes consecutive newly diagnosed patients with extranodal NK/T-cell lymphoma or one of the prespecified rare Epstein-Barr virus-positive T/NK-cell disease entities from 2026 through 2030.
Who may be able to join
- Age 18 years or older.
- Newly diagnosed Epstein-Barr virus-positive T/NK-cell lymphoproliferative disease meeting World Health Organization diagnostic criteria.
- For the retrospective cohort: diagnosis of extranodal NK/T-cell lymphoma between January 1, 2017 and December 31, 2025 at a participating center.
- For the prospective cohort: diagnosis between June 1, 2026 and December 31, 2030 of one of the following:
- Extranodal NK/T-cell lymphoma;
- Aggressive NK-cell leukemia;
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- Systemic chronic active Epstein-Barr virus disease of T/NK-cell type; or Epstein-Barr virus-positive nodal T/NK-cell lymphoma.
- Availability of essential diagnostic, staging, and treatment information.
- For the prospective cohort: written informed consent and successful collection of the protocol-required baseline peripheral blood specimen.
Who cannot join
- For the retrospective cohort: no usable survival follow-up information, inability to confirm survival status, or inability to calculate the principal survival outcomes.
- For the prospective cohort: unwillingness or inability to participate in protocol-defined longitudinal clinical follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Rong Tao, MD, 008621-64175590 ext. 660103, hkutao@hotmail.com
Chuanxu Liu, MD, 008621-64175590 ext. 660103, liuchaunxu@shca.or.cn
About this study
Official title: A Multicenter Ambidirectional Clinical and Biological Cohort Study of Epstein-Barr Virus-Positive T/NK-Cell Lymphoproliferative Diseases
This is a multicenter, non-interventional, ambidirectional cohort study of Epstein-Barr virus-positive T/NK-cell lymphoproliferative diseases. The study consists of a retrospective clinical cohort of 500 consecutively diagnosed patients with extranodal NK/T-cell lymphoma and a prospective clinical-biological cohort of 1,000 newly diagnosed patients with extranodal NK/T-cell lymphoma, aggressive NK-cell leukemia, systemic chronic active Epstein-Barr virus disease of T/NK-cell type, or Epstein-Barr virus-positive nodal T/NK-cell lymphoma.
The study will characterize clinical features, treatment pathways, response, relapse or progression patterns, and long-term survival. The prospective cohort will additionally undergo standardized collection of peripheral blood and optional tumor tissue specimens at predefined clinical time points. Clinical, molecular, viral, and immune biomarkers will be evaluated for their associations with treatment response, treatment failure, disease progression, and survival. No treatment is assigned by the study.
Read the detailed description
Epstein-Barr virus-positive T/NK-cell lymphoproliferative diseases comprise a heterogeneous spectrum of disorders that share viral and immunobiological features but differ substantially in clinical presentation, disease course, treatment, and prognosis. Extranodal NK/T-cell lymphoma is the principal disease entity in this study and will constitute the core population for clinical outcome analyses and development of integrated clinical-molecular prognostic models.
The study includes two cohorts. Cohort A is a retrospective cohort of approximately 500 consecutive hospitalized patients with newly diagnosed extranodal NK/T-cell lymphoma diagnosed between January 1, 2020 and December 31, 2025. Patients are identified through pathology records, followed by clinical verification and confirmation of survival follow-up. Cohort A includes clinical data only.
Cohort B is a prospective clinical-biological cohort of approximately 1,000 consecutive newly diagnosed patients enrolled between June 1, 2026 and December 31, 2030. Eligible disease entities include extranodal NK/T-cell lymphoma, aggressive NK-cell leukemia, systemic chronic active Epstein-Barr virus disease of T/NK-cell type, and Epstein-Barr virus-positive nodal T/NK-cell lymphoma. Extranodal NK/T-cell lymphoma will account for at least 80% of Cohort B.
Treatment is determined by treating physicians according to routine clinical practice and is not assigned by the study. Clinical information includes baseline disease characteristics, pathology, laboratory and imaging findings, treatment exposures, response assessments, adverse events, relapse or progression, subsequent treatment, and survival.
Prospective participants provide a 10-mL peripheral blood sample before treatment and are scheduled for additional sample collection after two treatment cycles, at the end of treatment or first formal end-of-treatment assessment, and at relapse or refractory disease confirmation. Plasma and peripheral blood mononuclear cells are stored in two aliquots at participating-center biobanks. Tumor tissue is optional. Molecular, viral, immune, and tumor microenvironment analyses will be performed within the scope approved by the protocol and informed consent.
The main clinical outcomes are overall survival and progression-free survival. Secondary outcomes include objective response rate, complete response rate, primary refractory disease, early progression, relapse or progression patterns, post-relapse survival, grade 3 or higher adverse events, serious infections, treatment-related mortality, and longitudinal changes in plasma Epstein-Barr virus DNA, circulating tumor DNA, and immune biomarkers.
- Conditions
- Extranodal NK/T-cell Lymphoma, Aggressive NK-Cell Leukemia, Systemic Chronic Active Epstein-Barr Virus Disease, Epstein-Barr Virus-Positive Nodal T/NK-Cell Lymphoma, Epstein-Barr Virus-Positive T/NK-Cell Lymphoproliferative Disease
- Keywords
- Epstein-Barr virus, T/NK-cell lymphoproliferative disease, extranodal NK/T-cell lymphoma, aggressive NK-cell leukemia, chronic active Epstein-Barr virus disease, EBV-positive nodal T/NK-cell lymphoma, circulating tumor DNA, plasma EBV-DNA, immune profiling, molecular biomarker
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell, Leukemia, Large Granular Lymphocytic, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective NKTCL Cohort | Approximately 500 consecutive hospitalized patients with newly diagnosed extranodal NK/T-cell lymphoma diagnosed between January 1, 2017 and December 31, 2025. Clinical, treatment, response, relapse, safety, and survival information is collected from medical records and follow-up records. No biospecimen collection is mandated. | |
| Prospective EBV-Positive T/NK Disease Cohort | Approximately 1,000 consecutive newly diagnosed patients enrolled between June 1, 2026 and December 31, 2030. Eligible diseases include extranodal NK/T-cell lymphoma, aggressive NK-cell leukemia, systemic chronic active Epstein-Barr virus disease of T/NK-cell type, and Epstein-Barr virus-positive nodal T/NK-cell lymphoma. Clinical information, longitudinal outcomes, and protocol-defined biospecimens are collected. Extranodal NK/T-cell lymphoma will represent at least 80% of this cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival is defined as the time from the date of initial diagnosis to death from any cause. Participants who are alive will be censored at the date on which their survival status was last confirmed.
Measured: From initial diagnosis to death or last confirmed follow-up, assessed for up to 10 years.
Progression-Free Survival
Progression-free survival is defined as the time from the date of initial diagnosis to the first documented disease progression, disease relapse, or death from any cause, whichever occurs first. Participants without an event will be censored at the date of the last assessment confirming absence of progression.
Measured: From initial diagnosis to progression, relapse, death, or last disease assessment, assessed for up to 10 years.
Secondary outcomes (4)
Objective Response Rate
The proportion of response-evaluable participants who achieve a best response of complete response or partial response during first-line treatment. The response-evaluable population includes participants who undergo at least one formal response assessment.
Measured: From initiation of first-line treatment through the first-line end-of-treatment assessment, assessed for up to 24 months.
Complete Response Rate
The proportion of response-evaluable participants who achieve complete response during first-line treatment.
Measured: From initiation of first-line treatment through the first-line end-of-treatment assessment, assessed for up to 24 months.
Grade 3 or Higher Adverse Events
The proportion of participants experiencing grade 3 or higher adverse events during systemic anticancer treatment, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Measured: During each treatment line, from treatment initiation through treatment completion, assessed for up to 24 months per treatment line.
Treatment-Related Mortality
The proportion of participants whose death is assessed as related to anticancer treatment.
Measured: From initiation of first anticancer treatment to 30 days after the last administered treatment, assessed for up to 10 years across treatment lines.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start11 Aug 2026
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Extranodal NK/T-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Rong Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rong Tao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727083
- Sponsor's protocol ID
- SHCA-EBV-T/NK-202601
- Acronym
- EBV-T/NK Cohor
- Status last verified
- Aug 2026
- First submitted
- 19 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be made publicly available because the current informed consent and multicenter data governance framework do not authorize unrestricted public sharing. Deidentified data may be considered for qualified scientific requests subject to approval by the study steering committee, participating institutions, and applicable ethics committees.
Publications
Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.
PubMed 25113753Li D, Liu C, Wan J, Zhang W, Ma Y, Zhu Y, Ma L, Tian S, Ding H, Tao R. Sintilimab, pegaspargase, and anlotinib as induction therapy for advanced-stage NKTCL: a multicenter phase II study. Blood Adv. 2026 Mar 3:bloodadvances.2025018720. doi: 10.1182/bloodadvances.2025018720. Online ahead of print.
PubMed 41774854Zhu Y, Tian S, Xu L, Ma Y, Zhang W, Wang L, Jin L, Liu C, Zhu C, Li Z, Hao S, Zhong H, Ding H, Tao R. GELAD chemotherapy with sandwiched radiotherapy for patients with newly diagnosed stage IE/IIE natural killer/T-cell lymphoma: a prospective multicentre study. Br J Haematol. 2022 Feb;196(4):939-946. doi: 10.1111/bjh.17960. Epub 2021 Nov 21.
PubMed 34806163Liu C, Ding H, Zhu Q, Liu P, Zhu Y, Wang L, Ma Y, Zhang W, Tian S, Zhang X, Jin L, Liu L, Li Z, Hao S, Tao R. Induction with MEDA regimen and consolidation with Auto-HSCT for stage IV NKTCL patients: A prospective multicenter study. Int J Cancer. 2022 Sep 1;151(5):752-763. doi: 10.1002/ijc.34055. Epub 2022 Jun 9.
PubMed 35489026Oishi N, Ahmed R, Feldman AL. Updates in the Classification of T-cell Lymphomas and Lymphoproliferative Disorders. Curr Hematol Malig Rep. 2023 Dec;18(6):252-263. doi: 10.1007/s11899-023-00712-9. Epub 2023 Oct 23.
PubMed 37870698Luniewski A, Chaudhary S, Goldfarb A, Obiorah IE. EBV-Driven NK/T-Cell Lymphoproliferative Disorders: Clinical Diversity and Molecular Insights. Lymphatics. 2026 Mar;4(1):7. doi: 10.3390/lymphatics4010007. Epub 2026 Jan 26.
PubMed 41657941
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Ambidirectional Clinical and Biological Cohort Study of Epstein-Barr Virus-Positive T/NK-Cell Lymphoproliferative Diseases
- ClinicalTrials.gov ID
- NCT07727083
- Acronym / sponsor ID
- EBV-T/NK Cohor / SHCA-EBV-T/NK-202601
- Conditions
- Extranodal NK/T-cell Lymphoma, Aggressive NK-Cell Leukemia, Systemic Chronic Active Epstein-Barr Virus Disease, Epstein-Barr Virus-Positive Nodal T/NK-Cell Lymphoma, Epstein-Barr Virus-Positive T/NK-Cell Lymphoproliferative Disease
- Keywords
- Epstein-Barr virus, T/NK-cell lymphoproliferative disease, extranodal NK/T-cell lymphoma, aggressive NK-cell leukemia, chronic active Epstein-Barr virus disease, EBV-positive nodal T/NK-cell lymphoma, circulating tumor DNA, plasma EBV-DNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Rong TaoUniversity, hospital or other
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, non-interventional, ambidirectional cohort study of Epstein-Barr virus-positive T/NK-cell lymphoproliferative diseases. The study consists of a retrospective clinical cohort of 500 consecutively diagnosed patients with extranodal NK/T-cell lymphoma and a prospective clinical-biological cohort of 1,000 newly diagnosed patients with extranodal NK/T-cell lymphoma, aggressive NK-cell leukemia, systemic chronic active Epstein-Barr virus disease of T/NK-cell type, or Epstein-Barr virus-positive nodal T/NK-cell lymphoma.
The study will characterize clinical features, treatment pathways, response, relapse or progression patterns, and long-term survival. The prospective cohort will additionally undergo standardized collection of peripheral blood and optional tumor tissue specimens at predefined clinical time points. Clinical, molecular, viral, and immune biomarkers will be evaluated for their associations with treatment response, treatment failure, disease progression, and survival. No treatment is assigned by the study.
Detailed description
Epstein-Barr virus-positive T/NK-cell lymphoproliferative diseases comprise a heterogeneous spectrum of disorders that share viral and immunobiological features but differ substantially in clinical presentation, disease course, treatment, and prognosis. Extranodal NK/T-cell lymphoma is the principal disease entity in this study and will constitute the core population for clinical outcome analyses and development of integrated clinical-molecular prognostic models.
The study includes two cohorts. Cohort A is a retrospective cohort of approximately 500 consecutive hospitalized patients with newly diagnosed extranodal NK/T-cell lymphoma diagnosed between January 1, 2020 and December 31, 2025. Patients are identified through pathology records, followed by clinical verification and confirmation of survival follow-up. Cohort A includes clinical data only.
Cohort B is a prospective clinical-biological cohort of approximately 1,000 consecutive newly diagnosed patients enrolled between June 1, 2026 and December 31, 2030. Eligible disease entities include extranodal NK/T-cell lymphoma, aggressive NK-cell leukemia, systemic chronic active Epstein-Barr virus disease of T/NK-cell type, and Epstein-Barr virus-positive nodal T/NK-cell lymphoma. Extranodal NK/T-cell lymphoma will account for at least 80% of Cohort B.
Treatment is determined by treating physicians according to routine clinical practice and is not assigned by the study. Clinical information includes baseline disease characteristics, pathology, laboratory and imaging findings, treatment exposures, response assessments, adverse events, relapse or progression, subsequent treatment, and survival.
Prospective participants provide a 10-mL peripheral blood sample before treatment and are scheduled for additional sample collection after two treatment cycles, at the end of treatment or first formal end-of-treatment assessment, and at relapse or refractory disease confirmation. Plasma and peripheral blood mononuclear cells are stored in two aliquots at participating-center biobanks. Tumor tissue is optional. Molecular, viral, immune, and tumor microenvironment analyses will be performed within the scope approved by the protocol and informed consent.
The main clinical outcomes are overall survival and progression-free survival. Secondary outcomes include objective response rate, complete response rate, primary refractory disease, early progression, relapse or progression patterns, post-relapse survival, grade 3 or higher adverse events, serious infections, treatment-related mortality, and longitudinal changes in plasma Epstein-Barr virus DNA, circulating tumor DNA, and immune biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective NKTCL Cohort | – | –Approximately 500 consecutive hospitalized patients with newly diagnosed extranodal NK/T-cell lymphoma diagnosed between January 1, 2017 and December 31, 2025. Clinical, treatment, response, relapse, safety, and survival information is collected from medical records and follow-up records. No biospecimen collection is mandated. |
| Prospective EBV-Positive T/NK Disease Cohort | – | –Approximately 1,000 consecutive newly diagnosed patients enrolled between June 1, 2026 and December 31, 2030. Eligible diseases include extranodal NK/T-cell lymphoma, aggressive NK-cell leukemia, systemic chronic active Epstein-Barr virus disease of T/NK-cell type, and Epstein-Barr virus-positive nodal T/NK-cell lymphoma. Clinical information, longitudinal outcomes, and protocol-defined biospecimens are collected. Extranodal NK/T-cell lymphoma will represent at least 80% of this cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older with a newly diagnosed Epstein-Barr virus-positive T/NK-cell lymphoproliferative disease meeting World Health Organization diagnostic criteria. The retrospective cohort includes consecutive hospitalized patients with extranodal NK/T-cell lymphoma diagnosed from 2017 through 2025. The prospective cohort includes consecutive newly diagnosed patients with extranodal NK/T-cell lymphoma or one of the prespecified rare Epstein-Barr virus-positive T/NK-cell disease entities from 2026 through 2030.
Key inclusion criteria (9 listed)
- Age 18 years or older.
- Newly diagnosed Epstein-Barr virus-positive T/NK-cell lymphoproliferative disease meeting World Health Organization diagnostic criteria.
- For the retrospective cohort: diagnosis of extranodal NK/T-cell lymphoma between January 1, 2017 and December 31, 2025 at a participating center.
- For the prospective cohort: diagnosis between June 1, 2026 and December 31, 2030 of one of the following:
- Extranodal NK/T-cell lymphoma;
Key exclusion criteria (2 listed)
- For the retrospective cohort: no usable survival follow-up information, inability to confirm survival status, or inability to calculate the principal survival outcomes.
- For the prospective cohort: unwillingness or inability to participate in protocol-defined longitudinal clinical follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival
Time frame: From initial diagnosis to death or last confirmed follow-up, assessed for up to 10 years.
Overall survival is defined as the time from the date of initial diagnosis to death from any cause. Participants who are alive will be censored at the date on which their survival status was last confirmed.
Progression-Free Survival
Time frame: From initial diagnosis to progression, relapse, death, or last disease assessment, assessed for up to 10 years.
Progression-free survival is defined as the time from the date of initial diagnosis to the first documented disease progression, disease relapse, or death from any cause, whichever occurs first. Participants without an event will be censored at the date of the last assessment confirming absence of progression.
4 secondary outcomes
Objective Response Rate
Time frame: From initiation of first-line treatment through the first-line end-of-treatment assessment, assessed for up to 24 months.
Complete Response Rate
Time frame: From initiation of first-line treatment through the first-line end-of-treatment assessment, assessed for up to 24 months.
Grade 3 or Higher Adverse Events
Time frame: During each treatment line, from treatment initiation through treatment completion, assessed for up to 24 months per treatment line.
Treatment-Related Mortality
Time frame: From initiation of first anticancer treatment to 30 days after the last administered treatment, assessed for up to 10 years across treatment lines.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 25113753Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.
- Results publication: PubMed 41774854Li D, Liu C, Wan J, Zhang W, Ma Y, Zhu Y, Ma L, Tian S, Ding H, Tao R. Sintilimab, pegaspargase, and anlotinib as induction therapy for advanced-stage NKTCL: a multicenter phase II study. Blood Adv. 2026 Mar 3:bloodadvances.2025018720. doi: 10.1182/bloodadvances.2025018720. Online ahead of print.
- Results publication: PubMed 34806163Zhu Y, Tian S, Xu L, Ma Y, Zhang W, Wang L, Jin L, Liu C, Zhu C, Li Z, Hao S, Zhong H, Ding H, Tao R. GELAD chemotherapy with sandwiched radiotherapy for patients with newly diagnosed stage IE/IIE natural killer/T-cell lymphoma: a prospective multicentre study. Br J Haematol. 2022 Feb;196(4):939-946. doi: 10.1111/bjh.17960. Epub 2021 Nov 21.
- Results publication: PubMed 35489026Liu C, Ding H, Zhu Q, Liu P, Zhu Y, Wang L, Ma Y, Zhang W, Tian S, Zhang X, Jin L, Liu L, Li Z, Hao S, Tao R. Induction with MEDA regimen and consolidation with Auto-HSCT for stage IV NKTCL patients: A prospective multicenter study. Int J Cancer. 2022 Sep 1;151(5):752-763. doi: 10.1002/ijc.34055. Epub 2022 Jun 9.
- Results publication: PubMed 37870698Oishi N, Ahmed R, Feldman AL. Updates in the Classification of T-cell Lymphomas and Lymphoproliferative Disorders. Curr Hematol Malig Rep. 2023 Dec;18(6):252-263. doi: 10.1007/s11899-023-00712-9. Epub 2023 Oct 23.
- Results publication: PubMed 41657941Luniewski A, Chaudhary S, Goldfarb A, Obiorah IE. EBV-Driven NK/T-Cell Lymphoproliferative Disorders: Clinical Diversity and Molecular Insights. Lymphatics. 2026 Mar;4(1):7. doi: 10.3390/lymphatics4010007. Epub 2026 Jan 26.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be made publicly available because the current informed consent and multicenter data governance framework do not authorize unrestricted public sharing. Deidentified data may be considered for qualified scientific requests subject to approval by the study steering committee, participating institutions, and applicable ethics committees.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extranodal NK/T-cell Lymphoma and Aggressive NK-Cell Leukemia, run by Rong Tao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rong Tao, MD (008621-64175590 ext. 660103, hkutao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From initial diagnosis to death or last confirmed follow-up, assessed for up to 10 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07727083, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.